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Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

Primary Purpose

Respiratory Tract Infections

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

BEZ235

BEZ235 plus everolimus (RAD001)

About this trial

This is an interventional prevention trial for Respiratory Tract Infections

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female subjects
Age ≥ 85 years
Age ≥ 65 and < 85 years with one or more of the following conditions:
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic bronchitis
- Type 2 Diabetes Mellitus (T2DM)
- Congestive Heart Failure (CHF) New York Heart Association (NYHA) functional classification I-II
- Current smoker
- One or more emergency room visits or hospitalizations for a RTI during the previous 12 months

Exclusion Criteria:

Subjects with medically significant cardiac conditions including NYHA functional classification III-IV
Subjects with Type I diabetes mellitus.
Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis
History of malignancy in any organ system within the past 5 years except for the following:
- Localized basal cell or squamous cell carcinoma of the skin, prostate cancer confined to the gland, cervical carcinoma in situ, breast cancer localized to the breast.
Subjects with any one of the following:
- hemoglobin < 10.0 g/dL for males and < 9.0 for females
- white blood cell (WBC) count < 3,500/mm3,
- neutrophil count < 2,000/mm3
- platelet count < 125,000/mm3
Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy
Recent surgery other than minor skin surgery
Liver disease or liver injury
History or presence of impaired renal function
History of immunodeficiency diseases
Subjects with active infection
Subjects with a Mini Mental Status Examination (MMSE) score <24 at screening.
Significant illness (based on the subject's medical history and the clinical judgement of the investigator) which has not resolved within two (2) weeks prior to initial dosing.

Sites / Locations

Heartland Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo once daily for 16 weeks

BEZ235 once daily for 16 weeks

BEZ235 twice daily for 16 weeks

BEZ235 plus RAD001 once daily for 16 weeks

Arm Description

Outcomes

Primary Outcome Measures

The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16

Secondary Outcome Measures

Percent of subjects who develop one or more RTIs through week 16

The rate of RTIs/person through week 16

The rate of RTIs per person through week 24

The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

Full Information

NCT ID

NCT03373903

First Posted

November 20, 2017

Last Updated

May 11, 2018

Sponsor

Restorbio Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03373903

Brief Title

Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

Official Title

A Multicenter, Dose-finding Study to Determine if Oral BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Restorbio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235 alone and in combination with RAD001 to support further development to reduce the incidence of respiratory tract infections (RTIs) in elderly subjects.

Detailed Description

This is a randomized, blinded, placebo-controlled, multicenter, parallel-group, dose finding 24-week study to assess the safety, tolerability and efficacy of up to 3 doses of BEZ235 alone and in combination with RAD001 as compared to placebo in elderly subjects who are at increased risk of respiratory tract infection related-morbidity and mortality. The study will be composed of up to a 6-week screening and run-in period, a 16-week treatment period and an 8-week follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

652 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo once daily for 16 weeks

Arm Type

Placebo Comparator

Arm Title

BEZ235 once daily for 16 weeks

Arm Type

Experimental

Arm Title

BEZ235 twice daily for 16 weeks

Arm Type

Experimental

Arm Title

BEZ235 plus RAD001 once daily for 16 weeks

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

BEZ235

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

BEZ235 plus everolimus (RAD001)

Intervention Description

Oral

Primary Outcome Measure Information:

Title

The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Percent of subjects who develop one or more RTIs through week 16

Time Frame

16 weeks

Title

The rate of RTIs/person through week 16

Time Frame

16 weeks

Title

The rate of RTIs per person through week 24

Time Frame

24 weeks

Title

The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24

Time Frame

24 weeks

Title

Peak Plasma Concentration (Cmax)

Time Frame

8 weeks

Title

Area under the plasma concentration versus time curve (AUC)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects Age ≥ 85 years Age ≥ 65 and < 85 years with one or more of the following conditions: Asthma Chronic Obstructive Pulmonary Disease (COPD) Chronic bronchitis Type 2 Diabetes Mellitus (T2DM) Congestive Heart Failure (CHF) New York Heart Association (NYHA) functional classification I-II Current smoker One or more emergency room visits or hospitalizations for a RTI during the previous 12 months Exclusion Criteria: Subjects with medically significant cardiac conditions including NYHA functional classification III-IV Subjects with Type I diabetes mellitus. Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis History of malignancy in any organ system within the past 5 years except for the following: Localized basal cell or squamous cell carcinoma of the skin, prostate cancer confined to the gland, cervical carcinoma in situ, breast cancer localized to the breast. Subjects with any one of the following: hemoglobin < 10.0 g/dL for males and < 9.0 for females white blood cell (WBC) count < 3,500/mm3, neutrophil count < 2,000/mm3 platelet count < 125,000/mm3 Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy Recent surgery other than minor skin surgery Liver disease or liver injury History or presence of impaired renal function History of immunodeficiency diseases Subjects with active infection Subjects with a Mini Mental Status Examination (MMSE) score <24 at screening. Significant illness (based on the subject's medical history and the clinical judgement of the investigator) which has not resolved within two (2) weeks prior to initial dosing.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarb Shergill, PhD

Organizational Affiliation

Restorbio Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33977284

Citation

Mannick JB, Teo G, Bernardo P, Quinn D, Russell K, Klickstein L, Marshall W, Shergill S. Targeting the biology of ageing with mTOR inhibitors to improve immune function in older adults: phase 2b and phase 3 randomised trials. Lancet Healthy Longev. 2021 May;2(5):e250-e262. doi: 10.1016/S2666-7568(21)00062-3. Epub 2021 May 6.

Results Reference

derived

Learn more about this trial

Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

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